BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 4251442 · Received November 14, 2014

    Report

    Report Number
    1722028-2014-00454
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    September 11, 2014
    Report Date
    October 21, 2014
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK130080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS RECORD WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF MDRS TO IDENTIFY RECORDS IN WHICH AN EVENT OCCURRED, BUT THE TYPE OF REPORTABLE EVENT WAS NOT INDICATED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE RBC BAG FROM A TRIMA ACCEL SET WAS RECEIVED. DRIED BLOOD WAS NOTED ON THE BAG, PARTICULARLY AT THE BOTTOM OF THE BAG. THE BAG INCLUDING THE PORTS WERE LEAK TESTED AND NO LEAKS COULD BE IDENTIFIED. NO DEFECTS OR DAMAGE TO THE BAG PORTS WERE OBSERVED. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. PER THE CUSTOMER, THE COLLECTION WAS COMPLETED AND THE BAG WAS SPIKED BY THE PATIENT¿S BED. THE NURSE DIDN¿T FIND ANY RESISTANCE WHILE INSERTING THE SPIKE INTO THE PRODUCT BAG. DURING TRANSFER OF THE PRODUCT, THE SPIKE BECAME DISCONNECTED AND LEAKED. SOME BLOOD DRIPPED ONTO THE NURSE,DOCTOR, AND PATIENT. THE CUSTOMER CONFIRMED THAT THE BLOOD DID NOT CONTACT ANY AREAS OF NON-INTACT SKIN OR MUCOUS MEMBRANE. ROOT CAUSE: ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, THERE WERE NO DEFECTS FOUND WITH THE BAG. BASED ON THE CUSTOMER¿S DESCRIPTION, IT IS LIKELY THAT EITHER THE SPIKE WAS NOT COMPLETELY INSERTED OR THERE WAS A DEFECT WITH THE SPIKE, WHICH WAS NOT A TERUMO BCT PRODUCT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PERFUSION SET GOT DISCONNECTED FROM THE BAG. THE DOCTOR, THE NURSE, AND THE PATIENT EXPERIENCED BLOOD SPRAY. IT IS NOT KNOWN AT THIS TIME IF MEDICAL INTERVENTION WAS NECESSARY FOR THIS EVENT. DUE TO EU PERSONAL DATA PROTECTION LAWS, THE PATIENT INFORMATION IS NOT AVAILABLE FROM THE CUSTOMER. THIS REPORT IS BEING FILED DUE TO THE POTENTIAL FOR INJURY IF THE SAME FAILURE WERE TO REOCCUR.

    Description of Event or Problem · 1

    NO MEDICAL INTERVENTION WAS NECESSARY FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737519 TRIMA ACCEL TRIMA ACCEL PLT,PLT FILTER,AUTOPAS,PLS,RBC,TLR FILTER GKT TERUMO BCT 06W2105

    Patients

    Seq Age Sex Outcome Treatment
    1 Other